Registration Dossier
Registration Dossier
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EC number: 944-283-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
FAT 20041 is considered as non-sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The room temperature varied between 21°C and 25°C during the study procedure
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- None
- Specific details on test material used for the study:
- None
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Females (if applicable) nulliparous and non-pregnant: 30 females / 6 females, nulliparous and nonpregnant
- Age at study initiation: 5 -7 weeks
- Weight at study initiation: Control and Test Group 259 - 381 g Pretest 269 - 315 g
- Housing: Individually in Makrolon type-3 cages with autoclaved standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 342, Batch no. 63/94 guinea pig breeding/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water.
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 21 and 25 °C
- Humidity (%): 52 and 70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Test Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5% with bi-distilled water.
3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Bi-distilled water
3)1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. - Day(s)/duration:
- Test Day 01
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in bi-distilled water
- Day(s)/duration:
- Test Day 08
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in vehicle
- Day(s)/duration:
- Test Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in test and 10 animals in control group
- Details on study design:
- None
- Challenge controls:
- None
- Positive control substance(s):
- yes
- Positive control results:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20041 is not a sensitiser.
- Executive summary:
A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20041 according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation).
No positive reactions were observed in the animals during the challenge phase either when treated with bidistilled water alone or when treated with the test article at 25 % in bidistilled water. FAT 20041 is therefore, classified as a non sensitiser in albino guinea pigs.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An in vivo guinea pig maximisation test was performed to determine the sensitization potential of FAT 20041 according to OECD Guideline 406 andEU Method B.6 (Skin Sensitisation).
No positive reactions were observed in the animals during the challenge phase either when treated with bidistilled water alone or when treated with the test article at 25 % in bidistilled water. FAT 20041 is therefore, classified as a non sensitiser in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data of the GPMT selected as key study, FAT 20041 does not warrant classification for skin sensitisation under the CLP (1272/2008) Regulation.
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